This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the lorad digital breast imager. The device generates digital mammographic images that can be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film mammographic systems.
| Device | LORAD DIGITAL BREAST IMAGER |
| Classification Name | Full Field Digital, System, X-ray, Mammographic |
| Generic Name | Full Field Digital, System, X-ray, Mammographic |
| Applicant | HOLOGIC, INC. |
| Date Received | 2001-04-30 |
| Decision Date | 2002-03-15 |
| Notice Date | 2002-04-25 |
| PMA | P010025 |
| Supplement | S |
| Product Code | MUE |
| Docket Number | 02M-0173 |
| Advisory Committee | Radiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HOLOGIC, INC. 36 Apple Ridge Road danbury, CT 06810 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P010025 | Original Filing | |
| S020 | 2010-06-29 | Normal 180 Day Track |
| S019 | 2010-06-01 | Normal 180 Day Track |
| S018 | 2010-02-03 | 30-day Notice |
| S017 | 2009-11-05 | Real-time Process |
| S016 | 2009-04-13 | 30-day Notice |
| S015 | 2009-02-09 | Real-time Process |
| S014 | ||
| S013 | 2008-04-30 | Normal 180 Day Track |
| S012 | 2008-04-01 | Real-time Process |
| S011 | ||
| S010 | 2007-03-12 | Real-time Process |
| S009 | 2006-11-24 | Real-time Process |
| S008 | 2005-10-24 | Normal 180 Day Track |
| S007 | 2005-06-24 | Normal 180 Day Track |
| S006 | ||
| S005 | 2004-05-07 | Normal 180 Day Track |
| S004 | 2003-12-19 | Real-time Process |
| S003 | 2003-04-15 | Normal 180 Day Track |
| S002 | 2003-03-28 | Real-time Process |
| S001 | 2002-03-29 | Normal 180 Day Track |